Purpose: Little is known about frailty in ACS patients and there is no information about the safety and efficacy of P2Y12 antagonists in this setting. We therefore assessed the impact of frailty in ACS patients enrolled in TRILOGY.
Methods: TRILOGY randomized 9326 patients with unstable angina or NSTEMI who were planned for medical management without revascularization to receive prasugrel (10 mg/d; 5 mg/d for patients ≥75 y or <60 kg) or clopidogrel 75 mg/d. The primary endpoint was a composite of cardiovascular death, MI, or stroke. The Fried Frailty Score was administered to 4699 (99.9%) patients >65 y. Score items included weight loss, exhaustion, physical activity, walk time, and grip strength. Association of frailty with the primary endpoint was adjusted for GRACE Risk Score covariates; HRs and 95% CIs are presented.
Results: 72.3% of patients were classed as not frail, 23.0% as pre-frail (1-2 items), and 5.1% as frail (≥3 items). Increasing frailty scores were associated with most risk factors and with increasing age: 0 items, 73.0 y; 1-2 items, 74.0 y; ≥3 items, 75.0 y; female sex (46.0%, 45.9%, and 50.2%); and higher GRACE scores (134.0, 138.0, and 144.0), respectively. Ischemic outcomes and bleeding are shown in the table. Frailty was significantly associated with the primary endpoint (pre-frail vs not frail: adjusted HR 1.33 [95% CI 1.11-1.60]; frail vs not frail: 1.55 [1.12-2.13], p<0.001).
Conclusions: Frailty is strongly associated with the composite of cardiovascular death, MI, or stroke as well as all-cause mortality. No association of frailty with bleeding was observed in the TRILOGY trial.